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Penile Cancer Treatment

General Information About Penile Cancer

Incidence and Mortality

Estimated new cases and deaths from penile (and other male genital) cancer in the United States in 2014:[1]

New cases: 1,640.

Deaths: 320.

Risk Factors

Penile cancer is rare in most developed nations, including the United States, where the rate is less than 1 per 100,000 men per year. Some studies suggest an association between human papillomavirus (HPV) infection and penile cancer.[2,3,4,5] Observational studies have shown a lower prevalence of penile HPV in men who have been circumcised (odds ratio, 0.37; 95% confidence interval, 0.16–0.85).[6] Some, but not all, observational studies also suggest that male newborn circumcision is associated with a decreased risk of penile cancer.[7,8] According to published data, if the relationship is causal, the number needed to treat was about 909 circumcisions to prevent a single case of invasive penile cancer.[9]

Treatment Overview

When diagnosed early (stage 0, stage I, and stage II), penile cancer is highly curable. Curability decreases sharply for stage III and stage IV. Because of the rarity of this cancer in the United States, clinical trials specifically for penile cancer are infrequent. Patients with stage III and stage IV cancer can be candidates for phase I and phase II clinical trials testing new drugs, biologicals, or surgical techniques to improve local control and distant metastases.

Cellular Classification of Penile Cancer

Although they are less common subtypes, warty carcinoma and basaloid carcinoma appear to be more highly associated with human papillomaviruses (HPV), particularly HPV 16, than typical squamous cell carcinoma or verrucous carcinoma of the penis.[3,4,5]

Stage 0 Penile Cancer

Stage 0 penile cancer is defined by the following TNM classifications:

Tis, N0, M0

Ta, N0, M0

Carcinoma in situ of the penis is referred to as erythroplasia of Queyrat when it occurs on the glans, and Bowen disease when it occurs on the penile shaft. These precursor lesions progress to invasive squamous cell carcinoma in 5% to 15% of cases. In case series studies, human papillomavirus DNA has been detected in the majority of these lesions.[2,3] With no data from clinical trials in this disease stage, treatment recommendations are largely based on case reports and case series involving limited numbers of patients.

Treatment options:

1.

Surgical excision can result in scarring, deformity, and impaired function. To minimize these effects, Mohs micrographic surgery, which involves the excision of successive horizontal layers of tissue with microscopic examination of each layer in frozen section, has been used in patients with in situ and invasive penile cancers.[4,5][Level of evidence: 3iiiDiv]

2.

Topical application of 5-fluorouracil cream has been reported to be effective in cases of erythroplasia of Queyrat [6] and Bowen disease.[7][Level of evidence: 3iiiDiv]

3.

Imiquimod 5% cream is a topical immune response modifier that has been reported to be effective with good cosmetic and functional results.[8,9,10][Level of evidence: 3iiiDiv]

4.

Laser therapy with Nd:YAG or CO2 lasers has also been reported to result in excellent cosmetic results.[11][Level of evidence: 3iiiDiv]

5.

Cryosurgery has been reported to result in good cosmetic results in patients with erythroplasia of Queyrat and verrucous penile carcinoma.[12,13][Level of evidence: 3iiiDiv]

Current Clinical Trials

Check for U.S. clinical trials from NCI's list of cancer clinical trials that are now accepting patients with stage 0 penile cancer. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

General information about clinical trials is also available from the NCI Web site.

Stage I Penile Cancer

For lesions limited to the foreskin, wide local excision with circumcision may be adequate therapy for control.

2.

For infiltrating tumors of the glans with or without involvement of the adjacent skin, the choice of therapy is dictated by tumor size, extent of infiltration, and degree of tumor destruction of normal tissue. Equivalent therapeutic options include:

Because of the high incidence of microscopic node metastases, elective adjunctive inguinal dissection of clinically uninvolved (negative) lymph nodes in conjunction with amputation is often used for patients with poorly differentiated tumors. Lymphadenectomy can carry substantial morbidity, such as infection, skin necrosis, wound breakdown, chronic edema, and even a low, but finite, mortality rate. The impact of prophylactic lymphadenectomy on survival is not known. For these reasons, opinions vary on its use.[9,10,11,12]

Current Clinical Trials

Check for U.S. clinical trials from NCI's list of cancer clinical trials that are now accepting patients with stage I penile cancer. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

General information about clinical trials is also available from the NCI Web site.

Stage II Penile Cancer

Stage II penile cancer is defined by the following TNM classifications:

T1b, N0, M0

T2, N0, M0

T3, N0, M0

Standard treatment options:

Stage II penile cancer is most frequently managed by penile amputation for local control. Whether the amputation is partial, total, or radical will depend on the extent and location of the neoplasm. External-beam radiation therapy and brachytherapy with surgical salvage are alternative approaches.[2,3,4,5,6]

Treatment options under clinical evaluation:

Nd:YAG laser therapy has been used to preserve the penis in selected patients with small lesions.[7]

Because of the high incidence of microscopic node metastases, elective adjunctive dissection of clinically uninvolved (negative) lymph nodes in conjunction with amputation is often used for patients with poorly differentiated tumors. Lymphadenectomy, can carry substantial morbidity, such as infection, skin necrosis, wound breakdown, chronic edema, and even a low, but finite, mortality rate. The impact of prophylactic lymphadenectomy on survival is not known.[8,9,10,11]

To reduce the morbidity associated with prophylactic lymphadenectomy, dynamic sentinel node biopsy is being used in patients with stage T2 clinically node-negative penile cancer. One retrospective single-institution study of 22 patients reported a false-negative rate of 11%.[12]

Current Clinical Trials

Check for U.S. clinical trials from NCI's list of cancer clinical trials that are now accepting patients with stage II penile cancer. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

General information about clinical trials is also available from the NCI Web site.

Stage III Penile Cancer

Stage III penile cancer is defined by the following TNM classifications:

T1–3, N1, M0

T1–3, N2, M0

Inguinal adenopathy in patients with penile cancer is common but may be the result of infection rather than neoplasm. If palpable enlarged lymph nodes exist 3 or more weeks after removal of the infected primary lesion and completion of a course of antibiotic therapy, bilateral inguinal lymph node dissection should be performed.

In cases of proven regional inguinal lymph node metastasis without evidence of distant spread, bilateral ilioinguinal dissection is the treatment of choice.[2,3,4,5] Since many patients with positive lymph nodes are not cured, clinical trials may be appropriate.

Clinical trials using radiosensitizers or cytotoxic drugs are appropriate. A combination of vincristine, bleomycin, and methotrexate has been effective as both neoadjuvant and adjuvant therapy.[7] Cisplatin (100 mg/m²) as neoadjuvant therapy plus continuous-infusion 5-fluorouracil has also been shown to be effective.[6] Single-agent cisplatin (50 mg/m2) was tested in a large trial and was found to be ineffective.[8]

Because of the high incidence of microscopic node metastases, adjunctive inguinal dissection of clinically uninvolved (negative) lymph nodes in conjunction with amputation is often used for patients with poorly differentiated tumors. Lymphadenectomy can carry substantial morbidity, such as infection, skin necrosis, wound breakdown, chronic edema, and even a low, but finite, mortality rate. The impact of prophylactic lymphadenectomy on survival is not known. [3,4,9,10]

To reduce the morbidity associated with prophylactic lymphadenectomy, dynamic sentinel node biopsy is being used in patients with stage T2 and stage T3 clinically node-negative penile cancer. One retrospective single-institution study of 22 patients reported a false-negative rate of 11%.[11]

Current Clinical Trials

Check for U.S. clinical trials from NCI's list of cancer clinical trials that are now accepting patients with stage III penile cancer. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

General information about clinical trials is also available from the NCI Web site.

Stage IV Penile Cancer

Stage IV penile cancer is defined by the following TNM classifications:

T4, Any N, M0

Any T, N3, M0

Any T, Any N, M1

No standard treatment exists that is curative for patients with stage IV penile cancer. Therapy is directed at palliation, which may be achieved either with surgery or radiation therapy.

Standard treatment options:

1.

Palliative surgery may be considered for control of the local penile lesion and even for the prevention of the necrosis, infection, and hemorrhage that can result from neglected regional adenopathy.

2.

Radiation therapy may be palliative for the primary tumor, regional adenopathy, and bone metastases.

Treatment options under clinical evaluation:

Clinical trials combining chemotherapy with palliative methods of local control are appropriate for such patients (tested chemotherapeutic drugs with some efficacy include vincristine, cisplatin, methotrexate, and bleomycin). The combination of vincristine, bleomycin, and methotrexate has been effective both as adjuvant and neoadjuvant therapy.[2]

Current Clinical Trials

Check for U.S. clinical trials from NCI's list of cancer clinical trials that are now accepting patients with stage IV penile cancer. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

General information about clinical trials is also available from the NCI Web site.

Recurrent Penile Cancer

Locally recurrent disease can be approached by surgery or radiation therapy. If the initial treatment of radiation therapy fails, patients are often salvaged by penile amputation. Patients with nodal recurrences that are not controllable by local measures are candidates for phase I and phase II clinical trials testing new biologicals and chemotherapeutic agents.[1,2,3,4,5]

Current Clinical Trials

Check for U.S. clinical trials from NCI's list of cancer clinical trials that are now accepting patients with recurrent penile cancer. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

General information about clinical trials is also available from the NCI Web site.

Changes to This Summary (03 / 07 / 2014)

The PDQ cancer information summaries are reviewed regularly and updated as new information becomes available. This section describes the latest changes made to this summary as of the date above.

General Information About Penile Cancer

Updated statistics with estimated new cases and deaths for 2014 (cited American Cancer Society as reference 1).

This summary is written and maintained by the PDQ Adult Treatment Editorial Board, which is editorially independent of NCI. The summary reflects an independent review of the literature and does not represent a policy statement of NCI or NIH. More information about summary policies and the role of the PDQ Editorial Boards in maintaining the PDQ summaries can be found on the About This PDQ Summary and PDQ NCI's Comprehensive Cancer Database pages.

About This PDQ Summary

Purpose of This Summary

This PDQ cancer information summary for health professionals provides comprehensive, peer-reviewed, evidence-based information about the treatment of penile cancer. It is intended as a resource to inform and assist clinicians who care for cancer patients. It does not provide formal guidelines or recommendations for making health care decisions.

Reviewers and Updates

This summary is reviewed regularly and updated as necessary by the PDQ Adult Treatment Editorial Board, which is editorially independent of the National Cancer Institute (NCI). The summary reflects an independent review of the literature and does not represent a policy statement of NCI or the National Institutes of Health (NIH).

Board members review recently published articles each month to determine whether an article should:

be discussed at a meeting,

be cited with text, or

replace or update an existing article that is already cited.

Changes to the summaries are made through a consensus process in which Board members evaluate the strength of the evidence in the published articles and determine how the article should be included in the summary.

The lead reviewers for Penile Cancer Treatment are:

Franco M. Muggia, MD (New York University Medical Center)

Andrew Stephenson, MD (Cleveland Clinic)

Any comments or questions about the summary content should be submitted to Cancer.gov through the Web site's Contact Form. Do not contact the individual Board Members with questions or comments about the summaries. Board members will not respond to individual inquiries.

Levels of Evidence

Some of the reference citations in this summary are accompanied by a level-of-evidence designation. These designations are intended to help readers assess the strength of the evidence supporting the use of specific interventions or approaches. The PDQ Adult Treatment Editorial Board uses a formal evidence ranking system in developing its level-of-evidence designations.

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